UveitisHOPENCT03155243
Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice
An observational study of Uveitis, run by AbbVie at 28 sites in 12 countries.
Trial summary
This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Uveitis
- How many people
- 155 participants
- Where
- 28 sitesin 12 countries
- Study dates
- 20 Jun 2017to 24 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with diagnosed active non- infectious intermediate, posterior or panuveitis (NIIPPU) that are being treated with Humira® as per locally approved label and prescription guidelines.
Who may be able to join
- Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable).
- Age >= 18 years at the time of the enrollment.
- Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:
- Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
- >= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
- >= 2+ vitreous haze [National Eye Institute (NEI)/SUN criteria]
- Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.
- Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.
Who cannot join
- Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines.
- Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
- Participants currently participating in other clinical research.
- Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.
Trial locations and contacts
28 sites in 12 countries.
28 sites in 12 countries
Israel6 sites
Barzilai Medical Center /ID# 163025
Ashkelon, 78278
Bnai Zion Medical Center /ID# 163026
Haifa, 3339419
Hadassah Medical Center /ID# 169305
Jerusalem, Jerusalem, 91120
Rabin Medical Center /ID# 163108
Petakh Tikva, Tel Aviv, 4941492
Sheba Medical Center /ID# 163109
Ramat Gan, 5262100
Tel Aviv Sourasky Medical Ctr /ID# 163024
Tel Aviv, Tel Aviv, 6423906
Greece4 sites
Omma /Id# 163750
Athens, 11525
Athens Eye Hospital /ID# 163751
Athens, 16675
University General Hospital of Ioannina /ID# 163752
Ioannina, 45500
Interbalkan Medical Center /ID# 163753
Thessaloniki, 57001
Colombia3 sites
Clinica Oftalmologica del Caribe /ID# 206448
Barranquilla, Atlántico, 080020
Foscal /Id# 207362
Bucaramanga, 680001
Fundacion hospitalaria San Vicente de Paul /ID# 208295
Medellín, 050010
Germany3 sites
Charite Campus Virchow-Klinikum /ID# 204879
Berlin, 13353
Universitätsklinikum Hamburg-Eppendorf /ID# 205234
Hamburg, 20251
St. Franziskus Hosp Muenster /ID# 206695
Münster, 48145
Switzerland3 sites
Inselspital, Universitaetsklinik /ID# 201027
Bern, 3010
Hop Ophtalmique Jules Gonin /ID# 201028
Lausanne, 1000
Stadtspital Triemli /ID# 206204
Zurich, Canton of Zurich, 8063
Austria2 sites
Medizinische Universität Graz /ID# 206301
Graz, Styria, 8010
Medical University of Vienna /ID# 206190
Vienna, State of Vienna, 1090
Hungary2 sites
Semmelweis Egyetem /ID# 163647
Budapest, 1085
Szegedi Tudomanyegyetem /ID# 163646
Szeged, 6720
United Arab Emirates1 site
Cleveland Clinic Abu Dhabi /ID# 210123
Abu Dhabi
About this study
Official title: Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice -HOPE
This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.
- Conditions
- Uveitis
- Keywords
- Humira®, Adalimumab, Ocular inflammation, Active non-infectious intermediate, posterior and panuveitis
- Medical subject headings
- Uveitis, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving adalimumab (Humira®) | Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieve treatment response at any of the follow-up visits
Definition of response: "quiescence" defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.
Measured: Up to Month 12
Secondary outcomes (16)
Proportion of participants with maintained response at any of follow up visits
Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.
Measured: Up to Month 12
Percent change in Presenteeism
Assessing percent change in presenteeism
Measured: Up to Month 12
Proportion of participants with maintained response separately for each follow-up visit
Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.
Measured: Up to Month 12
Percent Change in Total activity impairment
Assessing Percent Change in Total activity impairment
Measured: Up to Month 12
Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score
Assessing changes in total score of WPAI-UV score
Measured: From Month 1 to Month 12
Change in emergency room admissions
Assessing change in emergency room admissions
Measured: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Proportion of participants with treatment response separately for each follow-up visit
Response is defined as participants with no new active inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.
Measured: Up to Month 12
Change from baseline in Best corrected visual acuity (BCVA)
Assessing change from baseline in Best corrected visual acuity (BCVA)
Measured: From Month 1 to Month 12
Change in cumulative hospital admissions
Assessing change in cumulative hospital admissions
Measured: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in Central Retinal Thickness (CRT)
Assessing change from baseline in Central Retinal Thickness (CRT)
Measured: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Proportion of participants with flare at any of follow up visit
Flare is defined as new active inflammatory lesions or AC cell grade of >=2+ or VH grade of >=2+ at least in one eye.
Measured: Up to Month 12
Percent change in Absenteeism
Assessing percent change in absenteeism
Measured: Up to Month 12
Percent Change in Total work productivity impairment
Assessing Percent Change in Total work productivity impairment
Measured: Up to Month 12
Change in outpatient visits
Assessing change in outpatient visits
Measured: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change in hospitalization days prior to and during Humira® treatment
Assessing change in hospitalization days prior to and during Humira® treatment
Measured: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in intraocular pressure
Assessing change from baseline in intraocular pressure
Measured: From Month 1 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start20 Jun 2017
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155243
- Sponsor's protocol ID
- P16-537
- Acronym
- HOPE
- Status last verified
- Feb 2021
- First submitted
- 15 May 2017
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice -HOPE
- ClinicalTrials.gov ID
- NCT03155243
- Acronym / sponsor ID
- HOPE / P16-537
- Conditions
- Uveitis
- Keywords
- Humira®, Adalimumab, Ocular inflammation, Active non-infectious intermediate, posterior and panuveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving adalimumab (Humira®) | – | –Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with diagnosed active non- infectious intermediate, posterior or panuveitis (NIIPPU) that are being treated with Humira® as per locally approved label and prescription guidelines.
Key inclusion criteria (8 listed)
- Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable).
- Age >= 18 years at the time of the enrollment.
- Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:
- Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.
- Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.
Key exclusion criteria (4 listed)
- Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines.
- Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
- Participants currently participating in other clinical research.
- Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants who achieve treatment response at any of the follow-up visits
Time frame: Up to Month 12
Definition of response: "quiescence" defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.
16 secondary outcomes
Proportion of participants with maintained response at any of follow up visits
Time frame: Up to Month 12
Percent change in Presenteeism
Time frame: Up to Month 12
Proportion of participants with maintained response separately for each follow-up visit
Time frame: Up to Month 12
Percent Change in Total activity impairment
Time frame: Up to Month 12
Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score
Time frame: From Month 1 to Month 12
Change in emergency room admissions
Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Proportion of participants with treatment response separately for each follow-up visit
Time frame: Up to Month 12
Change from baseline in Best corrected visual acuity (BCVA)
Time frame: From Month 1 to Month 12
Change in cumulative hospital admissions
Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in Central Retinal Thickness (CRT)
Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Proportion of participants with flare at any of follow up visit
Time frame: Up to Month 12
Percent change in Absenteeism
Time frame: Up to Month 12
Percent Change in Total work productivity impairment
Time frame: Up to Month 12
Change in outpatient visits
Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change in hospitalization days prior to and during Humira® treatment
Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in intraocular pressure
Time frame: From Month 1 to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
28 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by AbbVie at 28 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Israel, Greece, Colombia, Germany, Switzerland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieve treatment response at any of the follow-up visits (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.